Trials (Dec 2019)

Examining the effects of a high-protein total diet replacement on energy metabolism, metabolic blood markers, and appetite sensations in healthy adults: protocol for two complementary, randomized, controlled, crossover trials

  • Camila L. P. Oliveira,
  • Normand G. Boulé,
  • Arya M. Sharma,
  • Sarah Elliott,
  • Mario Siervo,
  • Sunita Ghosh,
  • Aloys Berg,
  • Carla M. Prado

DOI
https://doi.org/10.1186/s13063-019-3950-y
Journal volume & issue
Vol. 20, no. 1
pp. 1 – 10

Abstract

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Abstract Background High-protein diets and total diet replacements are becoming increasingly popular for weight regulation; however, further research is needed to elucidate their impact on the physiology of body weight regulation. The aim of this inpatient metabolic balance study is to compare the impact of a high-protein total diet replacement versus a control diet (North American) on energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers and appetite sensations in healthy adults. Methods Two randomized, controlled, cross-over clinical trials conducted separately in men and women will be conducted. In each trial, participants will be allocated to two isocaloric arms: a) Control diet: 55% carbohydrate, 15% protein, and 30% fat; b) High-protein total diet replacement: 35% of carbohydrate, 40% protein, and 25% fat. They will receive the prescribed diets for 32 h while inside the whole-body calorimetry unit. Diets will be designed to ensure participants are in energy balance. The following physiological changes will be compared between groups: energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers, and appetite sensations. Body composition will be assessed at baseline using dual-energy X-ray absorptiometry. Discussion This will be the first inpatient metabolic balance study examining the impact of a high-protein total diet replacement on energy metabolism, metabolic blood markers and appetite sensations in healthy young adults (of both sexes) using a whole-body calorimetry unit. Results of this clinical trial can ultimately be used to develop strategies to optimize high-protein diet interventions and weight management. Trial registration ClinicalTrials.gov Identifiers: NCT02811276 (registered on 16 June 2016) and NCT03565510 (registered on 11 June 2018). Protocol version NCT02811276: version 10 (2 March 2018); NCT03565510: version 3 (28 September 2018).

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